Retiro De Equipo (Recall) de FC 500 Series Flow Cytometers (new, reconditioned or refurbished). An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Beckman Coulter Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    As a result of customer complaints and subsequent internal investigations, beckman coulter has determined that an internal electronic component on the circuit “amplifier” boards system may be affected by a manufacturing defect. each fc 500 system contains seven (7) of the potentially affected amplifier boards. all instruments are potentially impacted. there may be impact to patient results due to this issue when using the fc 500 for any application, which may result in failures causing signal loss and/or signal drifting. the failure could present itself as signal loss and/or signal drifting resulting in absence of data or a shift in the population in the data plots.Customers have reported sudden loss of signal, intermittent signal loss, sudden upward or downward shift in signal, upward or downward drift in signal over time, fluctuating signal, suboptimal compensation, erroneous results on affected parameters, and/or increased coefficients of variation (cv) of flow-check beads.
  • Acción
    All Applications including Laboratory Developed Tests, please review all data prior to the release of reported results from the lab and immediately implement the collection of Time as a parameter and create Time versus Parameter plots which will allow the monitoring of signal integrity during data acquisition For tetraCXP and stemCXP it is not possible to add time versus parameter, discontinue use of the automated tetraCXP and stemCXP applications. Users can continue to use the tetraCHROME reagents and Stem Kit reagents with the manual gating instructions provided in the product labelling. For ClearLLab Reagents, CytoDiff Application and Laboratory Developed Tests, in addition to the actions above ensure that the appearance of the data patterns are reviewed and look for suboptimal compensation and ensure that the pattern appearance matches the statistical data reported. For CytoDiff Application, in addition to the actions above, compare the results obtained from the cytometer to the results from the hematology analyzer for the same sample, and verify that there is concordance with the results. Contact Beckman Coulter Customer Technical Support Centre or the local Beckman Coulter Representative if any of the issues described occur. Consult with the Medical Director to determine if a retrospective review of results is warranted.


  • Modelo / Serial
    FC 500 Series Flow Cytometers (new, reconditioned or refurbished). An in vitro diagnostic medical device (IVD)All Part Numbers affectedAll Software Versions affectedARTG Number: 177999 (Beckman Coulter Australia Pty Ltd - Instrument/analyser IVDs)
  • Manufacturer